One such engineer got into the habit of collecting discarded soft parts from changeovers and visually inspecting them. His
curiosity and dislike of waste led him to ask whether there was a better way to systemize the replacement of these items so
that they were used for longer but without risking failure in operation. His involvement in a cross-industry benchmarking
group and discussions with his like-minded peers showed that better practices did exist. This knowledge spurred him to implement
a new way of working, leading to significant cost savings.
By following simple scientific and risk-based approaches, some companies are now extending the life of elastomers by three,
four, or five times. The previous time-based maintenance cycles have been replaced with condition-based cycles whereby the
wear and tear on the components are carefully analyzed and graded so that the life of the components can be accurately predicted.
The factors affecting wear and tear, such as the numbers of cleaning cycles, temperatures and chemicals used, are recorded
to provide a rational basis for analysis and later, measurement.
Operational data showing variations from predicted results are further sources of insight, shedding light on unknown factors
that lead to variability reduction and greater confidence levels predicting component condition. One such root-cause analysis
revealed that correct or incorrect assembly of diaphragm valves can contribute significantly to performance of the soft parts.
Correct lubrication of fixing bolts and accurate torque setting for instance was discovered to be a contributory factor in
the life of diaphragms.
The question of conformance to specification was another target-rich area with lack of clear standards and nonexistent or
inconsistent industry wide test methods. Elastomer suppliers have a long way to go to meet the exacting needs of the biopharmaceutical
environment. Performance has historically been the customer problem. Lack of control around changes being a particular concern
where the supply chain of suppliers and suppliers suppliers is not rigorously managed.
The same industry best-practice sharing group is now advancing the cause by proposing customer centric standards covering
generic-test sequences, visual inspection criteria, and better change control. With agreement by the various stakeholders,
these standards will be written into globally recognized codes that set the scene for better industry compliance.
In this example of a drive for best practice in biopharmaceutical manufacturing, one can trace a direct line from one engineer
examining the disassembled parts of a butterfly valve to a new industry system of standards and quality performance levels
previously not experienced.
Simon Chalk is director of the BioPhorum Operations Group, firstname.lastname@example.org